Clinical Document Control Specialist

Summary

Join PROCEPT BioRobotics as a Clinical Document Control Specialist, responsible for managing and maintaining clinical documentation to ensure regulatory compliance and internal quality standards. You will support clinical research teams by overseeing document lifecycle processes, facilitating audits, and ensuring proper archiving and retrieval of documents. This role requires a Bachelor's degree in a related field and 2-5 years of relevant experience. You will create and maintain clinical trial master files, ensure compliance with GCP and regulatory requirements, and develop and improve document control processes. The position offers a competitive salary, annual bonus, equity/RSUs, and a comprehensive benefits package.

Requirements

• Bachelor's degree in life sciences, regulator affairs, quality assurance, or a related field
• 2-5 years of experience in document control, clinical research, or regulatory compliance within the medical device or pharmaceutical industry
• Knowledge of GCP, FDA regulations (e.g., 21 CFR Part 11), EU MDR, and ISO 14155 standards
• Strong attention to detail and organizational skills
• Proficiency in electronic document management systems and Microsoft Office Suite
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple tasks simultaneously
• Work Authorization Status: Citizen / Permanent Resident

Responsibilities

• Create, organize, and maintain clinical trial master files (TMFs) and other essential clinical documentation
• Ensure all clinical documents are complete, accurate, and compliant with Good Clinical Practice (GCP) and regulatory requirements (e.g., FDA, ISO 14155, MDR)
• Manage version control and track document revisions to ensure all stakeholders have access to the latest versions
• Ensure all clinical documents meet regulatory and quality standards for submission to governing bodies
• Support internal and external audits by providing organized, comprehensive documentation
• Develop, implement, and improve document control processes to enhance efficiency and accuracy
• Train clinical team members on document control procedures and best practices
• Oversee the archiving of clinical documents
• Ensure timely and efficient retrieval of documents for inspections, audits, or project needs
• Maintain and manage electronic document management systems (EDMS) or clinical trial software tools when utilized
• Ensure system access controls and confidentiality of sensitive data

Preferred Qualifications

• Certification in Clinical Research or Regulatory Affairs (e.g., ACRP, RAPS)
• Familiarity with clinical trial management systems (CTMS)

Benefits

• Full medical coverage
• Wellness programs
• On-site gym
• A 401(k) plan with employer match
• Short-term and long-term disability coverage
• Basic life insurance
• Wellbeing benefits
• Flexible or paid time off
• Paid parental leave
• Paid holidays
• Annual bonus
• Equity/RSUs